4/14/2000 – Safety Study Skimping?

This article appeared yesterday on the ABC News site. We know
that drugs are given only cursory tests before being introduced
into the marketplace. Pharmaceuticals counter that they do
extensive follow-up testing (post-marketing) to assure that the
drugs are in fact safe. Now, it appears that this is something to
which they only give lip service. Mark

Report Says Drug Companies Fail to Complete Required Tests
When the Food and Drug Administration approves a drug it may
still have lingering questions about its safety or effectiveness
which it expects will be answered by the drug company.
(ABCNEWS.com)

By John McKenzie

N E W Y O R K, April 13 Evidence gathered by an
independent advocacy group suggests that many drug
companies in the United States are not keeping all of their
promises.

When a drug is approved by the Food and Drug Administration,
pharmaceutical firms are required to fulfill “post-marketing”
commitments to continue studying the safety and effectiveness
of the new product. Such research is necessary because the
FDA often approves drugs that have been tested on only a few
thousand people and lingering questions may remain about
how the drugs interact with other medicines or foods and what
kinds of side effects they may create in various patients.

The new study indicates, however, that many companies
routinely fail to follow through with these studies after the new
drugs reach the market. And the FDA is virtually powerless to do
anything about their lack of compliance.

The group that issued the report, Public Citizen, presented the
evidence to the FDA today, based on information obtained
through the Freedom of Information Act.

“Reliance on post-marketing studies as a way of safely
approving drugs is a dumb idea,” says Dr. Sidney Wolfe of Public
Citizen. “And a very dangerous idea because the studies mainly
are not getting done.”

Non-Compliance, No Consequences

According to Wolfe and the other authors of the report, FDA files
reveal that five drugs that were approved in the past decade and
later withdrawn from the market for safety reasons never had all
of their required follow-up studies completed.

And as of last December, only 11 out of the 88 new drugs that
were approved with post-marketing commitments between 1990
and 1994, had been subjected to the necessary studies or
properly filed the results. That€ ‘²s a compliance rate of just 13
percent.

“Five to ten years is certainly more than enough for the
overwhelming majority of these studies to be completed,” says
Dr. Brian Strom of the University of Pennsylvania. “The longer it
takes to answer these questions the longer patients are
exposed to potentially unnecessary risks.”

FDA Lacks Power

Representatives for the drug industry, however, say such studies
require greater patience.

“Specific studies that have to be designed, executed’. and if
they’re done in a comprehensive way they take a long time
to
do,” says Wayne Pines, a pharmaceutical industry spokesman.

But while the FDA can tell the drug companies to conduct
additional post-marketing studies, the fact is that once a drug is
on the market there’s little it can do to enforce the order.

Consumer advocates say Congress needs to give the FDA the
authority to impose fines on drug companies that break their
promises.

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